FDA issues guidance to help companies meet their first UDI direct marking deadline

UDI Deadlines

Device type

Label / GUDID / Date format requirements

Direct mark requirements

Class III devices

Devices licensed under the Public Health Services Act

Humanitarian use devices

Sept. 24, 2014

Sept. 24, 2015
- Lifesaving devices and
humanitarian device
exemption (HDE) devices

Sept. 24, 2016
- All other Class III devices

Implantable, life-supporting or life-sustaining devices

Sept. 24, 2015

Sept. 24, 2015

Class II devices

Sept. 24, 2016

Sept. 24, 2018

Class I, unclassified or not classified devices

Sept. 24, 2018

Sept. 24, 2020

Exceptions: Labelers of single-use orthopedics that are intended to be sterilized before use have until Sept. 24, 2016, to meet the GUDID requirements. Labelers of Class III contact and intraocular lenses have until Sept. 24, 2015, to meet the GUDID requirements.
Source: FDA guidance, "Unique Device Identifier System: Frequently Asked Questions, Vol. 1"

Industry is barreling toward its first direct marking requirement under the FDA's unique device identification (UDI) initiative. To help companies comply with the requirements, the agency released a Q&A-style guidance on the topic.

Unlike other guidance documents, this one is designed to be nontechnical (or as close to that as possible given the subject matter's nature) and does not contain any new policy announcements. Rather, it attempts to convey the essentials of the upcoming September deadline for the direct marking of high-risk class III devices (generally those requiring a PMA).

Direct marking refers to the affixation of the UDI permanently on the device itself (as opposed to its labeling). Here are some other key points that you should know:

  • The direct marking requirement is intended for devices intended to be used more than once and intended to be reprocessed before each use. That means many implants may not face the deadline.
  • The FDA does not specify a method for the direct marking of devices. The full UDI must be marked directly on the device, but it does not need to be identical to the UDI on the device label. For example, the directly marked UDI can contain both the plain text and machine-readable UDI, or just one or the other.
  • There are some exceptions to the requirement. The FDA can exempt a device from direct marking if it is not technologically feasible, has been previously marked, or if doing so would interfere with the safety and effectiveness of the device.
  • The FDA says that "for devices classified through the de novo process or cleared in a 510(k) submission, we expect you to conduct analysis and/or testing to determine whether direct marking could significantly affect the safety or effectiveness of the device and to document the basis for your determination in the design history file." But note that Class II devices face a 2018 deadline.

Those are the nontechnical quick hits. The Q&A also answers slightly more complicated questions, such as those related to the FDA's Global Unique Device Identification Database (GUDID) and definitions of technical (or legal) terms.

It's worth a read for those looking for a quick primer on the topic and focuses on just the upcoming deadline, to the exclusion of other extraneous information that would only make nervous companies even more harried and confused about compliance than they may be at this point.

- read the guidance